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Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML) (m-FLAI)

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ClinicalTrials.gov Identifier: NCT01247493
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : November 24, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)
Study Start Date : June 2007
Primary Completion Date : June 2009
Study Completion Date : July 2010


Arms and Interventions

Intervention Details:
    Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)
    fludarabine, cytarabine, idarubicin

Outcome Measures

Primary Outcome Measures :
  1. Complete remission rate
    Rate of complete remssion (CR) after two cycles of m-FLAI induction


Secondary Outcome Measures :
  1. Rate of serious adverse events (SAE)
    Number of patients dying from SAE related to m-FLAI induction

  2. Event Free Survival
    Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission

  3. overall survival
    Overall survival defined as a period from study enrollment to death from any cause

  4. Predictive factors for Complete remission
    Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previously untreated AML (excluding acute promyelocytic leukemia)
  • age greater than 60 years old
  • ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2
  • adequate hepatic/ renal/ cardiac function

Exclusion Criteria:

  • acute promyelocytic leukemia
  • significant cardiac disease
  • combined non-hematologic malignancy
  • aleukemic leukemia (only granulocytic sarcoma)
  • CNS (Central Nervous system) involvement
  • significant comorbidity/ uncontrollable bleeding tendency
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247493


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Inho Kim professor
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim, Inho professor, SeoulNUH
ClinicalTrials.gov Identifier: NCT01247493     History of Changes
Other Study ID Numbers: H-0704-029-205
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: November 24, 2010
Last Verified: November 2010

Keywords provided by Seoul National University Hospital:
fludarabine
AML
Efficacy
tolerability

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Fludarabine phosphate
Cytarabine
Idarubicin
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors